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Study of MK-4280A (Favezelimab and Pembrolizumab) for Patients with Metastatic Colorectal Cancer After Previous Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for , a type of cancer that affects the colon or rectum and has spread to other parts of the body after previous treatments. The study will compare a new treatment called , which is a combination of two substances, and , with standard treatments currently used for this condition. The standard treatments include medications like and a combination of and . The purpose of the study is to see how well works compared to these standard treatments in terms of helping patients live longer.

Participants in the study will receive either the new treatment or one of the standard treatments. The new treatment, , is given as a solution through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The standard treatments, and the combination of and , are taken orally in the form of tablets. The study will last for a period of time, during which the health and progress of the participants will be closely monitored by the research team.

The study aims to provide valuable information about the effectiveness of in treating that has not responded to previous treatments. By comparing the new treatment with existing options, researchers hope to find better ways to manage this disease and improve the quality of life for those affected. Participants will be randomly assigned to receive either the new treatment or one of the standard treatments, and some may receive a placebo. The results of this study could lead to new treatment options for patients with advanced .

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including having a type of colorectal cancer that has spread and cannot be removed by surgery.
A sample of the tumor is required, either from a previous biopsy or a new one, to ensure it meets the study's requirements.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the current state of the disease using specific criteria for measuring tumors.
The patient's ability to perform daily activities is assessed, and a life expectancy of at least three months is required.
Step 3
Treatment phase
The treatment involves receiving the study medication MK-4280A, which is a combination of two substances, favezelimab and pembrolizumab, administered through an intravenous infusion.
Alternatively, standard treatments such as regorafenib or a combination of trifluridine and tipiracil may be used, which are taken orally.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the response to the treatment, including measuring the size of the tumors and checking for any side effects.
Quality of life is evaluated using specific questionnaires to understand the impact of the treatment on daily living.
Step 5
Completion of the study
The study is expected to continue until November 2025, with regular assessments to determine the overall survival and progression-free survival.
Upon completion, the results will be analyzed to compare the effectiveness of the study medication against standard treatments.

Who can join the trial?

8 criteria

The patient must have a **confirmed diagnosis** of colorectal adenocarcinoma, which means a type of cancer that starts in the colon or rectum, and it must be **metastatic** (spread to other parts of the body) and **unresectable** (cannot be removed by surgery).
The patient must have **measurable disease** according to specific criteria used by doctors to assess tumors.
The patient must have been **previously treated** for colorectal cancer and the disease must have **progressed** (gotten worse) after treatment, or the patient could not tolerate the standard treatment.
The patient must provide a **tumor tissue sample** that is either from the past 5 years or newly obtained, and it must not have been treated with radiation before.
The patient must have an **ECOG Performance Score** of 0 to 1, which is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but nearly fully active.
The patient must have a **life expectancy** of at least 3 months, as judged by the doctor.
The patient must be able to **swallow and retain oral medication** and should not have any significant stomach or intestinal issues that could affect how the medicine is absorbed.
The patient must have **adequate organ function**, meaning the organs are working well enough to handle the treatment.

Who cannot join the trial?

4 criteria

Patients who have a different type of cancer other than Colorectal Cancer cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who are not eligible for the standard treatments being compared in the study, such as regorafenib or TAS-102, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Akershus University Hospital
Lorenskog, Norway
Verified
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Naples, Italy
Responsive
Universitetssykehuset Nord-Norge HF
Tromsø, Norway

Trial locations

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Investigated drugs

MK-4280A
is a combination of two medications, favezelimab and pembrolizumab. This combination is being studied to see if it can help people with a type of colorectal cancer that has already been treated and is positive for PD-L1. The goal is to see if this combination can help patients live longer compared to other treatments.
Regorafenib
is a medication used in this study as a standard treatment option. It works by blocking certain proteins that help cancer cells grow, which may help slow down or stop the growth of cancer.
TAS-102
is another standard treatment option in this study. It is a combination of two drugs that work together to interfere with the growth of cancer cells, potentially helping to control the cancer.

What is already known about the treatment

MK-4280A – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic colorectal cancer that is PD-L1 positive. It is a combination of two drugs, favezelimab and pembrolizumab, and is being compared to standard treatments like regorafenib or TAS-102. The main therapeutic indication is for patients who have previously been treated for this type of cancer. At the molecular level, MK-4280A works by targeting and inhibiting specific proteins that help cancer cells evade the immune system, thereby enhancing the body's ability to fight the cancer. It falls under the pharmacological classification of immune checkpoint inhibitors.

Investigated diseases

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. The disease may cause changes in bowel habits, such as diarrhea or constipation, and may also lead to blood in the stool. As it progresses, it can spread to other parts of the body, affecting organs and tissues beyond the colon and rectum. Early stages may not present noticeable symptoms, making regular screenings important for detection.